Application of a New Surgical Technique in Proximal Gastrectomy: a Prospective, Multicenter Randomized Controlled Study

Summary

This is a prospective study using a multicenter, randomized, controlled, open label, and efficacy validated approach.At present, there is no universally recognized optimal method for gastrointestinal reconstruction after proximal gastrectomy in the surgical treatment of gastric cancer.Author's team has proposed an innovative method named Hao's Esophagogastrostomay by Fisture Technique (HEFT).By adding anti reflux structures such as "false gastric fundus" and "false cardia" to the anastomosis of the residual stomach of the esophagus, not only can the purpose of anti reflux be achieved, but also the normal physiological channel can be maintained, it can fully utilize residual stomach function and reduce the difficulty of surgery.Through retrospective research, our single center has confirmed that HEFT is safe and feasible.On this basis, this study will compare the nutritional status, short- and medium- to long-term safety after laparoscopic HEFT and double-tract reconstruction , in order to evaluate and discover more reasonable digestive tract reconstruction methods after proximal gastrectomy, and to promote the development and popularization of minimally treatment technology for gastric cancer.

This study was jointly conducted by Shanghai-level hospitals (Huashan Hospital ,Shanghai Cancer Center, and Ruijin Hospital), with Huashan Hospital as the leading unit. This study will recruit 52 patients, with 26 patients in the experimental group and 26 patients in the control group. Using a central dynamic randomization method based on minimization, patients are assigned to groups in a 1:1 ratio. Based on the different anastomotic methods used in proximal gastrectomy, patients are divided into a HEFT group (experimental group) and a double-tract reconstruction group (control group).Plan to collect cases for 2 years, and follow up for another year after the last case is enrolled.

The primary endpoint of the study was the body weight loss (BWL) rate at 1 year after surgery. Secondary endpoints: Effect evaluation indicators: hemoglobin level at 1 year after surgery; Serum albumin level at 1 year after surgery; The incidence of anastomotic stenosis 1 year after surgery; Incidence of reflux esophagitis at 1 year after surgery. Evaluation of short-term surgical safety (duration: 7 days): operation time, intraoperative bleeding, anastomotic leakage, pancreatic leakage, and incidence of abdominal infection; Evaluation of medium- and long-term safety after surgery (duration: 36 months): overall survival rate at 3 years after surgery; disease-free survival rate at 3 years after surgery.

Conditions

• Gastric Cancer Patients Undergoing Minimally Invasive Gastrectomy

Interventions

PROCEDURE

Totally laparoscopic proximal gastrectomy with Hao's esophagogastrostomy by fissure technique

This is an innovative surgical method applied in proximal gastrectomy. By adding anti reflux structures such as "false gastric fundus" and "false cardia" on the basis of esophageal residual gastric anastomosis, the goal of anti reflux is achieved, while maintaining normal physiological channels and fully utilizing residual gastric function, reducing the difficulty of proximal gastrectomy surgery

PROCEDURE

Totally laparoscopic proximal gastrectomy with double-tract reconstruction

This is a traditional surgical method that has been widely used in proximal gastrectomy. After disconnecting the proximal stomach, performing Roux-en-Y anastomosis of the esophagus and jejunum firstly, followed by lateral anastomosis of the residual stomach and jejunum. Previous studies have confirmed its safety and effectiveness, but there are also issues of gastric channel disuse and high missed detection rate of residual stomach.

Sponsors & Collaborators

• Ruijin Hospital

  collaborator OTHER

• Shanghai Cancer Hospital, China

  collaborator OTHER

• Huashan Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-04

Primary Completion

2029-06-30

Completion

2029-06-30

Countries

• China

Study Locations